1. Field of the Invention
The present invention relates to the field of receiving and counting instruments for surgical "sharps", i.e., surgical needles and blades and other small surgical implements capable of being magnetically attracted prior to their disposal. More specifically, the invention relates to the field of manufacture of containers used to receive these instruments during an operation and which provide a systematic means for counting the implements after use and/or as they are removed from the body of the patient. Finally, the present invention provides an inexpensive means of disposing of the sharps after the operation is completed.
2. Description of the Prior Art and Other Information
During virtually every surgical procedure, sharp implements ("sharps"), such as surgical ["suture"] needles and ["scalpel"] blades and hypodermic needles are utilized, and, following the surgical procedure, must be counted and discarded in a safe manner. First, surgical practice has long recognized the danger of the possibility that small surgical instruments may be left within the body of a patient during surgical procedures. Even the most acute visual inspection of the patient may not reveal the presence of some types of small surgical implements which are left in the patient's body, and, therefore, an accounting system is often used. The number of implements available to the surgeon are counted prior to the operation and again counted as they are removed from the patient's body. The lack of an implement at the end of the operation indicates that it has been misplaced and possibly inadvertently left within the patient's body, and an exhaustive search of the operating room and patient, including the incision, must be performed until the implement is found. If necessary, an X-ray search of the patient is performed.
Although the implements may be routinely counted before the operation, during the closure of the incision the count must be made with great rapidity so as not to extend materially the amount of time that the patient is under surgery. Moreover, if the counting and disposal aspects of the sharps are ignored, injury to and infection of the patient may occur. This process of counting the implements can be facilitated by devices which are used to retain the blades, surgical needles, staples, and other small instruments and implements as they are used and/or removed from the patient, as the case may be. Such devices are best represented by FIGS. 1-6 hereto and the descriptions in U.S. Pat. Nos. 4,243,140 to Thrun; 4,193,496 to Barratt; 4,167,230 to Barratt; 4,013,109 to Sandel; 3,944,069 to Eldridge; 3,861,521 to Burtz; and 3,727,658 to Eldridge. To perhaps a somewhat lesser extent the devices described in U.S. Pat. Nos. 4,182,448 to Huck et al.; 4,116,333 to Pavel; 4,105,115 to Horvath et al.; 4,076,882 to Fenster et al.; 4,008,802 to Freitag; 3,819,039 to Erickson; and 3,697,223 to Kovalcik et al. are also pertinent. While these relatively expensive devices have been partially successful in the counting and disposal of sharps, they have virtually ignored a competing problem--the accelerating cost of hospital disposables, which have, no doubt, added to the total rate of inflation of hospital costs--including physician fees, hospital supplies, laboratory costs and room and board--which rate of inflation, over a decade, has been roughly double that of the general economy.
As seen below, various prior art and state of the art devices have been designed to aid nursing personnel in counting sharps. One of the more popular versions consists of a rubber pad to which a series of magnets are attached. The used needles and blades are held in place by the magnets, thus facilitating count. Upon conclusion of the operating procedure, the magnets, rubber pad, and the used blades are discarded.
U.S. Pat. No. 4,243,140 to Thrun is representative of the state of the art in disposable sharps containing devices in which no magnet is utilized; while the device provides an excellent means of counting devices, the necessity of having to place sharps such as needles 46 or 44 into slots 60 or in resilient material 38 is time-consuming; moreover, the device is lightweight and can be easily jarred which would risk loss of the contents in the surrounding environment with more loss of time to find all the instruments.
U.S. Pat. No. 4,193,496 to Barratt (see FIG. 6 attached hereto) also represents a state of the art device using a system of a disposable advanced bottom tray and top cover that, when closed and in a nested configuration, are capable of securely encasing sharps therebetween. See col. 2, lines 26-64. The description at col. 5, lines 48-62 discloses a resilient material 34 which "may be an array of magnetic strips, or the like . . . the material 34 may be coated with a layer of adhesive, or an array of magnetic strips, or the like . . . the material 34 may be formed with a series of raised ridges through which needles and sutures, etc., may be passed for retention". Any possible use of magnets in Barratt 4,193,496 are, therefore, to be employed in the disposable device, which would again provide a safer means of receiving and counting the sharps than an embodiment without such magnets, but, unfortunately, would make the device again relatively expensive.
Barratt, in U.S. Pat. No. 4,167,230, also discloses a disposable receiver comprised of tray and cover elements which are confined to nest in a closed position: note FIG. 4 in 4,167,230 having cover 114 with base 112 wherein the base 112 may be attached to strip magnets 40 (see FIGS. 1-3 of 4,167,230) to attrack the sharps, i.e., tray device 36 comprises a foamed sheet 38 with a plurality of strip magnets 40 adhered to the upper surface of the sheet. See col. 3, lines 47-53 and col. 4, lines 17-29. The magnets presumably would be discarded with the rest of the device.
U.S. Pat. No. 4,013,100 to Sandel discloses a hinged sterilizable container for magnetizable surgical instruments, having magnetic means which completely cover the interior portion of the case to retain any magnetizable instruments placed within the case. Specifically, Sandel 4,013,100 uses magnet means 120 covering lower portion 14 of case 10 by an adhesive to collect ferrous-containing materials. Again, the magnets would not be resuable.
U.S. Pat. Nos. 3,727,658 (see FIGS. 1, 3 and 4 hereto) and 3,944,069 to Eldridge, Jr. (see FIG. 2 hereto), each disclose a disposable receiver for surgical implements comprising a pair of foldably connected pads which employ a plurality of magnetic bars to attempt to retain the sharps. However, we found that it is easy when using the 3,727,658 and 3,944,069 devices to have the sharps extend beyond the periphery of the device, which extension would present a hazard to operating room personnel, or worse yet, could cause the loss of the sharps in the operating room when the device is folded just prior to disposal. Moreover, FIG. 1 of the 3,727,658 also reveals by instrument 5 another problem: if an instrument is bound to two magnets 37 N" and "S" on each side of the hinge, it is likely to be lost from the device entirely when the device is folded. Again, the magnets of these devices are lost when the device is discarded.
U.S. Pat. No. 3,861,521 to Burtz discloses yet another disposable suture containing and needle organizer having pockets 11-15 or 21-28, and magnets 25. Again, the magnets would have to be discarded with the device upon disposal of the latter.
Perhaps less pertinent in Huck et al., U.S. Pat. 4,182,448, disclosing a receiver for disposing of used surgical sharps, particularly needles and needle blades, comprising an adhesive-coated 18, rectangular backing panel 11 having a cover panel 14 and two matrix panels 12 and 13 attached along the sides thereof. No magnet is employed. U.S. Pat. No. 4,116,333 to Pavel discloses a dispenser for sewing machine needles (in a non-analogous art, infra) employing a collecting means and cover means. U.S. Pat. No. 4,105,115 to Horvath et al. discloses a holder for retaining sutures, needles and other surgical products used during surgical operations, with one form of the holder being made from sheet material and having intermediate portions folded over adjacent intermediate portions thereof to form a plurality of V-shaped pockets which are adapted to receive and to retain the sutures and needles. Again, no magnets are utilized. U.S. Pat. No. 4,076,882 to Fenster et al. discloses foldable disposable pads having a layer of polyurethane on a layer of cardboard, part of the polyurethane foam having a pressure sensitive adhesive thereon. No magnets are involved. Presumably, the device would be utilized in the manner of Eldridge 3,727,658 and 3,944,069 above. Freitag, in U.S. Pat. No. 4,008,802 (see FIG. 6) teaches the manufacture of a pad of resilient material through which needles can be inserted, the pad provided with consecutively numbered needle receiving zones formed by ridges upstanding from an upper face of the pad, and by transversely extending lines across the ridges. This is similar in some respects to Erickson, U.S. Pat. No. 3,819,039, which teaches the manufacture of resilient material having a series of parallel slits defining abutments which bear against surgical sutures positioned in the slits to hold them securely and conveniently in place. Kovalcik et al., in U.S. Pat. No. 3,697,223, shows an autoclave tray for holding instruments wherein the instruments are placed on form-fitting intermediate trays in the container.